Pharma Packaging Line Lead - 1st Shift, Data-Driven Operator

ARx Pharma; Glen Rock (York County); On-site; USD 55,000 - 85,000; Full time

Job summary

ARx Pharma seeks a packaging process professional to assist in developing, scaling up and validating packaging processes for specialty drug delivery products in compliance with 21 CFR 211 and related regulatory standards.

You will collaborate with Engineering, Operations, and Quality to ensure successful outcomes on the ARx packaging lines. Expect to work on the line, support validation, and participate in continuous improvement initiatives.

Qualifications

• Associates degree or 5-10 years of mechanical/maintenance work on packaging equipment.
• Experience in cGMP manufacturing environment desirable.
• Ability to learn practical technical skills (LEAN, design control, validation, experimental design).
• Proficiency with MS Office and basic data handling.

Responsibilities

• Work with engineers to develop new/modified packaging processes.
• Provide oversight to the packaging process and monitor the line.
• Execute experiments and validation protocols per 21 CFR 211 standards.
• Collect data, analyze results, and generate reports with recommendations.
• Contribute to cleaning processes and changeover requirements.
• Assist in design records to support development and production.
• Communicate effectively with teammates and customers.
• Support deviations investigations and corrective actions.
• Lead on packaging line activities as needed.
• Perform other duties as assigned.

Skills

Cross-functional teamwork

Data interpretation

Communication

Organizational skills

Multitasking

On-line packaging line knowledge

Education

Associate degree in technical competency

5-10 years mechanical/maintenance experience

Tools

Excel

Word

PowerPoint

Outlook

Statistical software

Job description

ARx Pharma seeks a packaging process professional to assist in developing, scaling up and validating packaging processes for specialty drug delivery products in compliance with 21 CFR 211 and related regulatory standards.

You will collaborate with Engineering, Operations, and Quality to ensure successful outcomes on the ARx packaging lines. Expect to work on the line, support validation, and participate in continuous improvement initiatives.